Treatment of vault prolapse

ABSTRACT

Apparatus for forming an artificial tie or ligament between different internal parts within a mammalian body, the apparatus comprising a strip ( 10 ) of preferably mesh type fabric formed of a material which is suitable for remaining in the body, and a drawstring ( 12 ) which is looped between different points along the length of the strip ( 10 ). By drawing the drawstring ( 12 ) the length of the strip ( 10 ) can be reduced. Opposite ends of the strip ( 11, 13 ) are in use attached to the different internal parts, and then those parts can be pulled together by applying tension to the drawstring ( 12 ), and once the length of the strip ( 10 ) has been reduced, tying off the drawstring ( 12 ) to hold the strip ( 10 ) in its reduced length condition. The apparatus is specifically useful for use in a in a method of treating vault or vaginal prolapse. The invention extends to a method of treating vault or vaginal prolapse.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a national phase application and claims priorityfrom PCT Application. No. PCT/AU02/00369, filed on Mar. 27, 2002, whichclaims priority from Australian Patent Application No. PR 4065, filed onMar. 28, 2001. Both applications are hereby incorporated by reference intheir entirety.

FIELD OF THE INVENTION

This invention relates to the treatment of vaginal or vault prolapse andto a device suitable for use in such treatment. The device might be usedin other medical procedures.

BACKGROUND OF THE INVENTION

Vault or vaginal prolapse is a condition which occurs in women who haveundergone a medical procedure such as a hysterectomy which has resultedin the utero-sacral ligaments which hold the vagina in position withinthe body cavity being severed or damaged. The result of such damage isthat the vagina has a tendency to invert which is uncomfortable andunhealthy, and renders the vagina unsuitable for intercourse.

The condition has in the past been treated using one of variousdifferent procedures. Abdominal colposacropexy for example involvesabdominal surgery which is undesirable. Zacharin's abdominal operationis another documented procedure in which the vagina is attached directlyto the pelvic floor. Vaginal enterocole repair involves the attachmentof the vault to the ileococcygeus muscle followed by posterior repair.Petros' infra-coccygeal sacropexy uses a nylon tape to “recreate” theutero-sacral ligaments.

Procedures performed via abdominal incision are particularly invasiveand therefor not the preferred form of treatment. Procedures performedvaginally are however difficult to perform due to the close confines inwhich the procedure needs to be performed and the narrow passagewaythrough which the surgeon must operate. It will be appreciated thatattaching the distal end of the vagina to the pelvic floor in such amanner that the vagina is properly aligned and that the artificialligaments thus created are of correct length and tension requires agreat deal of skill and dexterity. An aim of the present invention is tofacilitate the aforementioned vaginal procedure.

SUMMARY OF THE INVENTION

In broad terms the invention comprises a strip of fabric or mesh formedof a material adapted to remain within the body cavity after a procedurehas been performed therewith, the strip incorporating a drawstring whichextends between at least two points separated lengthwise along thestrip, the drawstring being configured such that tension applied to thedrawstring will assist in causing the length of the strip between thetwo points to be reduced.

Preferable the invention provides apparatus for forming an artificialtie or ligament between a first internal part, and a second, different,internal part, within a mammalian body, the apparatus comprising a stripof flexible material adapted to remain within the body after a procedurehas been performed therewith, the strip incorporating a drawstring whichextends between at least two points separated lengthwise along thestrip, the drawstring being configured such that when one point has beenattached to a first internal part of the body, and the other part pointhas been attached to a second internal part of the body, a tensionapplied to the drawstring will assist in causing the length of the stripbetween the two points to be reduced, and retain the strip in itsreduced length condition, thereby forming said artificial tie orligament between said first and second parts.

The strip is preferably made of a light mesh formed of an absorbable ornon-absorbable thread. Suitable material might comprise proprietarymaterials such as Vypro™ or Prolene™ or Vycral™. The mesh openings areprobably between 1 mm and 8 mm in diameter.

The drawstring is preferably threaded in and out, through the meshopenings, so that tension applied to the drawstring will tend to causethe strip to adopt a gathered configuration. The drawstring ispreferably threaded in such a manner that the two ends of the drawstringare aligned parallel with each other and aligned with the length of thestrip, the two ends being adapted to be tied together to retain thestrip in its reduced length condition. The drawstring may be configuredso that a mechanical advantage is obtained by applying tension to thedrawstring. The configuration might comprise looping the drawstring atleast twice between said points so that drawing the drawstring a certainlength will reduce the length of the strip by half that length.

The strip may have a central region removed therefrom and the drawstringmay be looped around said central region.

The invention extends to a method of treating vaginal prolapse whichcomprises attaching a strip of the type defined above between the pelvicfloor and the vault, using the drawstring to reduce the length of thestrip, thereby pulling the vault towards the pelvic floor, and tying thedrawstring off to maintain the strip in its reduced length condition,thereby forming a tie between the vault and the pelvic floor.

In the preferred form of the invention two strips are attached in thismanner to the pelvic floor, on opposite sides of the rectum fromopposite sides of the vault. The strip or strips are preferably attachedto the cardinal ligament area of the vault.

Where the procedure is performed vaginally it will first be necessary toopen the posterior floor of the vagina to obtain access to the pelvicfloor.

It will be appreciated that the strip of the invention could well haveapplication in surgical procedures in addition to that of treatment ofvault prolapse.

These and further features of the invention will be made apparent fromthe description of preferred embodiments thereof given below by way ofexample. In the description reference is made to the accompanyingdrawings, but the specific features shown in the drawings should not beconstrued as limiting on the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a plan view of a strip of mesh according to the invention;

FIG. 2 shows a plan view of another strip of mesh according to theinvention;

FIG. 3 shows a perspective view of a strip according to the inventionfixed in portion between two locations in a body, the strip being in itsreduced length condition;

FIG. 4 shows a sectional side view of a patient with two stripsaccording to the invention in place on opposite sides of the vagina; and

FIG. 5 shows a similar view to that of FIG. 4 but with the strips intheir reduced length condition after the drawstrings have been tightenedand tied off.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Referring initially to FIGS. 1 to 3, a strip 10 according to theinvention is formed of a length of mesh material which convenientlycomprises a wide mesh formed of a Vypro thread and is adapted to be leftpermanently within the body as a permanent ligament. The strip 10 has afirst end 11 which in use will be attached to the pelvic floor of apatient, and a second end 13 which in use will be attached to thevaginal wall of the patient. The manner in which the strip will be usedis described in more detail below.

A drawstring 12 is threaded in and out though the mesh openings so as toform an M-shaped double loop, with the two free ends 14 of thedrawstring extending parallel with each other towards the one end 13 ofthe strip. The effect of the drawstring being in this double loopconfiguration is that the drawstring connects together two points of thestrip, numbered 16 and 18 in the drawings. It will be appreciated thatpulling on the ends 14 of the drawstring will have the effect ofshortening the two loops, causing the strip to gather or pleat betweenthe two points 16 and 18, thereby effectively shortening the strip.

The strip has a central portion 20 in which the mesh material has beenremoved, the central portion being located in the region of the stripbetween the two points 16 and 18. Removing the mesh from the centralportion has the effect of reducing the quantity of mesh material in theregion of the strip which is gathered after pulling on the drawstring.

It will be appreciated that the double loop configuration of thedrawstring is selected so that a mechanical advantage is obtained whenpulling on the drawstring to thereby facilitate the shortening of thestrip. Pulling the two ends of drawstring a set length will shorten thestrip by half of that length. Of course, other configurations ofdrawstring threading will achieve a different mechanical effect.

In FIG. 2 a similar strip 38 is depicted to that shown in FIG. 1 but thedrawstring 40 has only a single free end 42 whilst the other end 44 issecured to the mesh. The drawstring 40 is threaded through the meshopenings to form one and a half loops around the central opening 46 andpulling on the end 42 in the direction of arrow 48 will cause thedrawstring to tighten around the central opening 46 thereby effectivelyreducing the length of the strip. A disadvantage of this embodiment isthat tying off the drawstring is more difficult, but in someapplications this might not be a problem and may be advantageous.

FIG. 2 also shows a variation in which the drawstring 40A is not loopedback around the opening 46 to terminate at its anchored end 44. Rather,that portion of the drawstring has a free end 42A so that the entiredrawstring has a U-shaped configuration. The drawstring may optionallybe anchored at the bight of the U. Tightening of the drawstring isachieved by pulling on the free-ends 42 and 42A in the direction ofarrows 48 and at the same time pushing on the mesh in the direction ofarrow 49. This is achieved by pushing the vaginal wall 26 towards thepelvic floor 28, and thereafter tying off the free ends 42 and 42A ofthe drawstring.

A yet further embodiment is illustrated in chain outline at 50, andessentially represents a continuation of the drawstring 40 in mirrorimage having the mechanical advantage of that drawstring configurationwith the added advantage of symmetrical gathering up of the mesh and theability to tie off both free ends 42 and 51.

As shown in FIG. 3 of the drawings the strip 10 is attached via firstend 11 to a first location point which, in the treatment of vaultprolapse, will be the pelvic floor 28. The other end 13 will be attachedto the other attachment point which, in the treatment of vault prolapse,will be the vaginal wall 26. It will be noted that the end 13 comprisesa length of mesh material which is about half of the entire length ofthe strip 10. The drawstring 12 is threaded through the first end 11 ofthe strip. Clearly, the second end 13 of the strip may be attached atany point along its length so as to be able to accommodate physiologicaldifferences in female patients. The commonest point of attachment of themesh of the vaginal vault is adjacent the central opening 20, that is,at location 16 on the mesh. The mesh may be reinforced at this point toprovide for more secure attachment to the vaginal vault. Excess stripmaterial can, if desired, be cut from the end 13 either prior to orduring the attachment procedure.

Once the ends 11 and 13 have been attached to their respective locationsin the body the drawstring 12 will be pulled up and the two ends tiedoff. It will be noted from FIG. 3 that the end 11 has been gathered up,considerably reducing the overall length of the strip 10. The gatheredportion of the strip is indicated at numeral 15.

In use for treatment of vault prolapse, two strips will be connectedbetween opposite sides of the vagina and the pelvic floor. Thearrangement is clearly shown in FIGS. 4 and 5 of the drawings.

The first stage of the procedure is to open the posterior vaginal wall26 to obtain access to the pelvic floor 28. The pelvic floor 28 isexposed on either side of the rectum 30 thereby providing locationswhere two strips 10 can be attached to the pelvic floor.

The respective ends 11 of the two strips are then attached to theexposed locations on the pelvic floor by suturing. The sutures cansimply attach the mesh material itself to the pelvic floor, butpreferably the sutures pass around the drawstring so as to form a secureattachment point for the drawstring of each strip. Thereafter the otherends 13 of the two strips are attached to the cardinal ligament area oneach side of the vault. Clearly, exactly where along the length of thestrip the attachment to the vault is made will depend on the patient'sphysiology, and typically the actual attachment point will be somedistance away from the distal end 13.

Once both ends of both strips 10 have been attached between the pelvicfloor and the vault the surgeon will begin closing the posterior vaginalwall. Once partially closed the drawstrings can be used to pull thevault closer to the pelvic floor. Pulling on the drawstrings will, asdiscussed above, shorten the strips, and since the strips connect thevault to the pelvic floor, the vault will effectively be pulled towardsthe pelvic floor. Since there are two strips, each with its respectivedrawstring, the surgeon can ensure that the vagina is correctly alignedand positioned. The drawstrings allow the final alignment andpositioning to be done when the vaginal wall incision is partiallyclosed making the whole operation that much easier to perform.

Once the vagina has been pulled into the correct position, the two endsof each drawstring will be tied together, thereby securing each strip inits reduced length condition, permanently holding the vagina inposition. The strips are made from a material specifically adapted to beleft in place in the body, and will in time form artificial ligamentsconnecting the vagina to the pelvic floor.

The posterior vaginal wall will then be completely closed and ifrequired the perineal body can be refashioned. Very little if anyvaginal mucosa need be excised. As mentioned above, it is desirable thatthe procedure is performed vaginally since this greatly reduces patientmorbidity.

FIG. 5 depicts the two strips in position after the drawstrings havebeen tied off.

Clearly there may be many variations to the above described embodimentwithout departing from the scope of the invention. Clearly the strip canbe configured differently to that described herein, and can be made of adifferent material. For example, the two individual strips 10 mayconverge at their base in the manner indicated in broken outline at 54in FIG. 3, resulting in Y-shaped configuration with the individualdrawstrings being fed through each arm of the Y.

As mentioned above, the drawstring can be threaded differently. However,the advantage of being able to pull the vagina into position at arelatively late stage of the operation will greatly facilitate achievingoptimal alignment of the vagina, even though the operation is performedvaginally.

It is envisaged that a mesh or fabric in strip form will best be used toform the apparatus of the invention. However, it should be appreciatedthat in some applications a strip as such might not be necessary. Forexample, a longitudinally extending narrow tube might be used in someapplications, or a chord-like elongate element might also be used. Thedrawstring will generally be connected to the ligament defining elongateelement in such a way that relative sliding between the drawstring andthe elongate element will result in the aforementioned length reductionof the elongate element, as the drawstring has tension applied to it.

The term “drawstring” as used herein is intended to have a broadinterpretation and will include any filament that can be used to reducethe length of an element connected between two internal parts within abody. The term “tie” likewise is to be given broad interpretation and isused to describe a connector which is able to act under tension to holdtwo parts together.

It will be understood that the invention disclosed and defined hereinextends to all alternative combinations of two or more of the individualfeatures mentioned or evident from the text or drawings. All of thesedifferent combinations constitute various alternative aspects of theinvention.

The foregoing describes embodiments of the present invention andmodifications, obvious to those skilled in the art can be made thereto,without departing from the scope of the present invention.

1. Apparatus for forming an artificial tie or ligament between a firstinternal part, and a second, different, internal part, within amammalian body, the apparatus comprising a strip of flexible materialadapted to remain within the body after a procedure has been performedtherewith, the strip incorporating a drawstring which extends in aU-shape or loop back configuration between at least two points separatedlengthwise along the strip, the drawstring being configured such thatwhen one point has been attached to a first internal part of the body,and the other part point has been attached to a second internal part ofthe body, a tension applied to the drawstring will assist in causing thelength of the strip between the two points to be reduced, and retain thestrip in its reduced length condition, thereby forming said artificialtie or ligament between said first and second parts.
 2. Apparatusaccording to claim 1 wherein the strip comprises a fabric or meshmaterial.
 3. Apparatus according to claim 2 wherein the strip iscomprised of a light mesh formed of either an absorbable, or anon-absorbable thread.
 4. Apparatus according to claim 3 wherein themesh has openings of between 1 mm and 8 mm in diameter.
 5. Apparatusaccording to claim 3 wherein the drawstring is threaded in and out,through the mesh openings, so that tension applied to the drawstringwill tend to cause the strip to adopt a gathered configuration. 6.Apparatus according to claim 5 wherein the drawstring has a centralregion and two end regions, the end regions being free of the strip, theend regions being adapted to be tied together to hold the strip in itsgathered configuration.
 7. Apparatus according to claims 5 wherein thedrawstring is configured such that mechanical advantage is obtained byapplying a tension to the drawstring.
 8. Apparatus according to claim 7wherein the drawstring is looped at least twice between said points sothat drawing the drawstring a certain length will reduce the length ofthe strip by half that length.
 9. Apparatus according to claim 5 inwhich the strip is configured to adopt a gathered configuration by theadditional application of force to the mesh in the direction ofgathering.
 10. Apparatus according to claim 1 wherein a central regionof the strip, between said two points, has been removed and thedrawstring is looped around said central region.
 11. Apparatus accordingto claim 1 wherein the strip of flexible material has a Y-shapedconfiguration, with at least one drawstring being carried on each arm ofthe Y.
 12. Apparatus for forming an artificial tie or ligament betweendifferent internal parts within a mammalian body, the apparatuscomprising a first elongate flexible member, and a second elongateflexible member, each member being formed of a material adapted toremain for at least a significant time within the body, the secondelongate flexible member being attached to the first elongate flexiblemember at at least two points, the attachment at at least one pointbeing a slidable attachment and the second elongate flexible memberbeing in a U-shape or loop back configuration such that tension appliedto the second flexible member, relative to the first flexible memberwill cause the first flexible member to reduce in length, over at leastpart of its length, opposite end regions of the first elongate memberadapted to be attached to different respective parts within a said body.13. A method of treating vaginal prolapse using at least one elongateflexible member having a drawstring extending between two pointsseparated lengthwise along the member, the method comprising the stepsof: attaching said member between the pelvic floor and the vault, usingthe drawstring to reduce the length of the member, thereby pulling thevault towards the pelvic floor, and tying off the drawstring to maintainthe member in its reduced length condition, thereby forming a tiebetween the vault and the pelvic floor.
 14. A method according to claim13 wherein two elongate members are attached to the pelvic floor, onopposite sides of the rectum, and to opposite sides of the vault, andthe drawstrings of both elongate members are used to reduce the lengthof their respective elongate members, the drawstrings then being tiedoff.
 15. A method according to claim 13 wherein the procedure isperformed vaginally by opening the posterior floor of the vagina toobtain access to the pelvic floor.
 16. A method of forming an artificialtie between two internal parts of a mammalian body using at least oneelongate flexible member having a drawstring extending between twopoints separated lengthwise along the member, the method comprising thesteps of: attaching said flexible member between said parts; using thedrawstring to reduce the length of the member, thereby drawing the twoparts together; and tying off the drawstring to maintain the elongatemember in its reduced length condition, thereby forming a tie betweensaid parts.